Product News and Recalls

Dietary supplements make up bulk of FDA recalls

A study published in the medical journal JAMA Internal Medicine concluded that more than half of all U.S. Food and Drug Administration drug recalls between 2004 and 2012 with a potentially dangerous “Class I” designation were for dietary supplements.

Class I is reserved for products with a reasonable possibility of causing “serious health consequences or death.” Of the 465 drugs recalled under that designation, 237 were dietary supplements.

A report on the study in Forbes says the FDA classifies a drug as a dietary supplement if it’s taken by mouth and contains a “dietary ingredient” such as vitamins, minerals, herbs, botanicals, or amino acids. Supplements can be legally sold on the U.S. market without FDA approval, according to the story.

The story says there are about 65,000 dietary supplements currently on the market. The category with the highest rate of FDA recalls, accounting for 40 percent, was sexual enhancement. The next two highest categories were bodybuilding and weight loss.

The supplements subject to recalls, some of which are manufactured abroad, have been “adulterated” with potentially dangerous ingredients, including steroids.

And although the FDA is legally required to contact the manufacturer and start a recall if it learns of such an adulterated product, the sheer number of companies around the world manufacturing supplements makes it difficult for the agency to keep track of them.

According to Forbes, the FDA is starting a number of initiatives aimed at mitigating the impact of the most common adulterated supplements. Those initiatives include the formation of multinational enforcement groups, as well as media campaigns to spread awareness of the issue.

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